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Peter J Mansfield, Independent Health Adviser Good Healthkeeping,, Garrod House, Manby, LOUTH LN11 8UT
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During the systematic review of water fluoridation which spanned 1999-2000 (1), the dearth and poor quality of scientific evidence was a major concern. In particular, no acceptable measurements were yet available of fluoride consumption from all sources in any random sample of the British population. The National Diet and Nutrition Survey published in 2003 (2) the first such data, from 24-hour urinary fluoride assays from most survey subjects. Urinary values were dealt with in Volume Three of the report . The authors inferred that 1% of men and 3% of women had intakes of fluoride above the officially defined safe level of 0.05mg/kg/day. Whilst reviewing the raw survey data for another research purpose I checked this statement. A serious error came to light in the authors’ calculation. The authors seem to have assumed that all fluoride consumed from any source is excreted promptly in the urine. In fact, 90% of ingested fluoride is assimilated into the blood stream (3), and half of that is sequestered in calcified tissues. Only the remaining half, 45% of the ingested fluoride, is excreted via the urine (4). On this basis daily fluoride consumption is higher than daily excretion by a factor of 2.2. When this correction is made, a much larger proportion of the sample is shown to have consumed fluoride at or above the nationally defined safe level. The correct figures range from 8.2% among 19-24 year old females to 25.5% for males aged 50-64.The mean for the entire sample (1429) is 20.2%. This sample does not distinguish subjects receiving fluoridated water from those who do not. Some 24-hour urines were incomplete, so these findings under-estimate the truth. The result suggests that a substantial proportion of the British population are consuming fluoride in amounts that could be responsible for undiagnosed symptoms. Persons accidentally consuming fluoride in excessive amounts deserve to be identified and helped. It is time to raise medical and dental awareness of this. Might not a square to detect fluoride concentration be added alongside glucose to the urine testing dipstick? The authors of the Survey Report and the relevant civil servant have been advised of this apparent error, and have not refuted it. The Food Standards Agency is considering its response. References 1 McDonagh M, Whiting P, Bradley M et al. A systematic review of water fluoridation. NHS Centre for Reviews and Dissemination: University of York, 2000. 2 Henderson L, Irving K, Gregory J. The national diet and nutrition survey: adults aged 19 to 64 years. HM Stationery Office, 2003;3:129-135. 3 World Health Organisation Monograph Series No 59. Fluorides and Human Health. Geneva: World Health Organisation, 1970:75-89. 4 National Research Council (US). Health effects of ingested fluoride. Washington: National Academy Press,1993:128-133. Competing interests: None declared |
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Colwyn M Jones, Consultant in Dental Public Health Edinburgh EH8 9RS
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The systematic review of water fluoridation by the York centre for reviews and dissemination (York CRD) concluded that water fluoridation works. It found that an extra 14.6% of children would be completely free of tooth decay with the misery it engenders, and a later estimate of the preventive fraction is a 40% overall reduction in decay (Worthington, 2003). So we can all agree water fluoridation works. The glaring omission from the article by Cheung et al is mention of the pain, disfigurement, embarrassment and cost that preventable dental decay causes. Although rare, death under general anaesthesia does tragically happen and tooth extraction is the commonest clinical indication for general anaesthesia for children in Scotland. Water fluoridation works as it does not rely on behaviour change and a number of Cochrane reviews confirm that fluoride in many forms (toothpaste, mouthrinses, etc.) is complementary to water fluoridation. Cheng et al develop their section on safety by selectively quoting from the literature in citing an ecological study. The study conducted multiple statistical comparisons and only one was significant at the 5% level, a probability you would expect by chance. Rather alarmingly Cheung et al then use this data to calculate excess bladder cancer rates in the UK. However, the original authors state, “Our study found an excess rate of bladder cancer that was restricted to females...... there is no reason to expect sex differences in bladder cancer..... Therefore, the possibility that this is a chance result should be considered....” Equally spurious would have been to calculate the reduction in other types of cancer and suggest water fluoridation has a protective effect. Most systematic reviews conclude that the evidence base is poor. Cheung et al are correct on the necessity for future research on water fluoridation, and with an estimated 40% reduction in disease it should be a priority. How can we do this? We must introduce a number of large water fluoridation schemes and thoroughly evaluate this population based, public health measure using modern research methods to demonstrate it works, confirm safety and see if early indications are correct that it reduces socio-economic inequalities in dental health. The sooner we get started the better. References Worthington HV and Clarkson J. The evidence base for topical fluorides. Community Dental Health (2003)20:74-76. Competing interests: Dentist Member of the British Fluoridation Society |
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Douglas W Cross, Independent Consultant in Environmental Analysis Croft End, Lowick Bridge, Cumbria LA12 8EE
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The medicinal nature of the product fluoridated water is not in doubt, since it conforms to both definitions of a medicinal product provided in Article 1.2 (a) and (b) of the latest version of the European Communities medicines directive [1]. It is unquestionably medicinal by presentation and by function. A number of European Court of Justice (ECJ) rulings confirm that the intent to medicate, or even deliberately giving the public the impression that a substance has medicinal properties, is the criterion defining a substance or product as ‘medicinal’:
‘If a product is represented to the public so that any averagely well-informed person gains the impression that the substance might have a beneficial effect on some medical condition, then that substance is a medicine under the terms of this Directive.’ [2] In the Ter Voort decision the ECJ ruled that: 'A product that is recommended or described as having preventive or curative properties is a medicinal product . . . even if it is generally considered as a foodstuff and even if it has no known therapeutic effect in the present state of scientific knowledge', The nature of a product as medicinal is established by legal definition, whereas the award of a marketing authorization by the Medicines and Healthcare Products Regulatory Authority (MHRA) is an administrative decision subject to political influence. A medicinal product is, and remains, medicinal regardless of whether or not the MHRA has awarded it a licence. The designation of fluorosilicates as source materials for fluoride in water under the Water Act 2003 does not constitute legal authority for their use as medicinal substances. Dilution is not an issue – even water for injection requires, and has, a medicinal product marketing authorisation, since it is used with the intent to medicate. The argument that fluoridated water is a food is tenable only if it is not a medicinal product. Any food, including water, that contains a medicinal substance is regulated under the medicines directive. If fluoridated water were to be classed as a food then it would be subject to the directives regulating food supplements and/or food additives. Supplements, and the materials from which they may be derived, are strictly controlled: '(Preamble 9) – Controversy as the identity of those nutrients that could potentially arise should be avoided. Therefore it is appropriate to establish a positive list of those vitamins and minerals.’ [3] Annex I of the directive sets out in this positive list; the permissible sources of Annex I substances are specified in Annex II. Only the source substances identified in Annex II may be used as supplementary sources of the named vitamins and minerals. Sodium and potassium fluoride are the only authorised source materials for the ‘mineral’ fluoride. The fluorosilicates used in water fluoridation are not ‘substantially equivalent’ to ‘natural’ or any other fluorides, and are absent from Annex II. All food supplements must be delivered to the consumer in concentrated pre-packed form. Their promotion as having medicinal properties is prohibited: 'Article 6. No food supplement – including any mineral – may be presented to the public as having medicinal properties.’ It is therefore improper to refer to fluoridated water as providing a ‘supplementary’ source of fluoride for consumers, since this implies that it is a permitted food supplement. The practice of ‘fortifying’ the fluoride content of drinking water to reach the ‘optimal’ concentration recommended for dental health protection is improper – the objective of the European Community’s water quality standards is to ensure that the quality of water is the highest possible, not the worst permissible. When added to a food, including water, then vitamins and minerals (and certain other technical substances essential for the processing of foods) are classed as additives. The directive regulating the addition of vitamins and minerals and certain other substances to foods [4] lists all permissible food additives in Annex I. No fluoride or fluorosilicate is included in this list; their addition to any food is therefore prohibited, and this would also apply to fluoridated milk targeted at children. Since fluoridated water is either an unlicensed medicinal product or a food containing an unauthorised additive (or, indeed, both), placing it upon the market is prohibited, and any form of advertising that the product has medicinal properties is banned. As the directives are transposed into UK (and Irish) domestic law, advertising fluoridated water as having medicinal properties is an offence. For example, Clause 3 of the UK Medicines (Advertising) Regulations 1994 [5] states: ‘No person shall issue an advertisement relating to a relevant medicinal product in respect of which no product license is in force.’ This clearly acknowledges that unlicensed medicinal products do exist, and that the absence of a product licence granted by the MHRA does not prevent such a product from being classed as medicinal in law. Similarly, rules on the labelling, presentation and advertising of foods [6] prohibit attributing any ‘preventing, treating or curing properties’ to foods. This has been interpreted by the ECJ as banning all health claims relating to human diseases. [7] ‘Publishing’ and ‘advertising’ are interpreted in extremely wide terms [8], which include issuing verbal recommendations for the adoption of fluoridation for the prevention of dental caries to health professionals, executive agencies and the general public. The ethical implications of doing so, especially for health care professionals, are serious, since offenders may be vulnerable to actions in law by any person claiming to have been damaged by the practice. The provision of ‘consultation’ processes on implementing new fluoridation schemes is also contrary to law, since there can be no debate on whether or not to commit a criminal assault upon the public. The provision of any form of professional or corporate indemnity for such liability, including that offered by the British Government to water companies[9], is at risk – there can be no indemnity for a criminal act. References. 1. 2004/27/EC on medicines for human use (OJ L 136, 30.4.2004 p.34) 2. Case C-60/89, 21 March 1991, re Manteil and Samanni, European Court Reports 1991;I:1547; Case C219-91, 28 October 1992, re Ter Voort, European Court Reports 1992;I:5485; Case C368-88, 21 March 1991 re Delattre, European Court Reports 1991;I:1487; Case C227-82, 30 November 1983, re van Bennekom, European Court Reports 1983;3883 3. 2002/46/EC on Food Supplements (OJ L 183. 12.7.2002, p51 4. 2006/52/EC amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs (OJ L 204, 27.7.2006 p 1-13) 5. Medicines (Advertising) Regulations 1994 (SI 1994 No. 1932) 6. 2000/13/EC on labelling, presentation and advertising of foods (OJ L 109, 6.5.2000, p 29) 7. Case C221-00, Judgement of 23/1/2003, Commission/Autriche (Rec. 2003, p.I-1007) 8. 65/65/EEC on medicinal products (OJ No 22 of 9.2.1965, p 369/65) 9. The Water Supply (Fluoridation Indemnities)(England) Regulations 2005 (SI 2005 No. 920) Competing interests: None declared |
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Michael A Lennon, Professor and Honorary Consultant in Dental Public Health University of Sheffield
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The recent paper by Cheng et al(1) questions the benefits of water fluoridation. The systematic review conducted by York CRD(2) used two outcome measures of dental benefit. Evidence rated below level B (moderate quality; moderate risk of bias) was excluded from this aspect of the review; twenty-six studies were included (all level B). First, York showed that the proportion of caries-free children increased by 14.6% in fluoridated districts. Worthington and Clarkson(3), Co-ordinating Editor and Editor respectively of the Cochrane Oral Health Group, have described such a change in the proportion of caries- free children as “a huge reduction in caries”. In their second calculation York CRD showed that water fluoridation reduced the extent of dental caries by a mean of 2.25 decayed, missing and filled teeth. Worthington and Clarkson(3) calculate this as equivalent to a “preventive fraction” of 40%. This is close to the figure calculated from a different data set and widely circulated by the British Fluoridation Society(4) and others since 1994. The national caries data cited by Cheng et al hide significant regional variations, and no one to my knowledge has, over the past twenty years, proposed a “national” fluoridation programme for the UK. If we extended water fluoridation from the current 10% to around 30% of the population, there would be substantial benefits for the many disadvantaged young children living in deprived areas in the UK with the highest levels of dental caries. Professor M. A. Lennon OBE. Chair, British Fluoridation Society References 1. Cheng KK, Chalmers I, Sheldon TA. Adding fluoride to water supplies. British Medical Journal 2007;335:699-702. 2. McDonagh MSPF, Whiting, et al. Systematic review of water fluoridation. British Medical Journal 2000;321: 855-859. 3. Worthington HV, Clarkson J. The evidence base for topical fluorides (editorial). Community Dental Health 2003;20:74-76. 4. British Fluoridation Society. One in a Million - the facts about water fluoridation. Manchester: British Fluoridation Society, 2004 http://www.bfsweb.org/onemillion/onemillion.htm. Competing interests: Chair (unpaid) British Fluoridation Society |
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John F Beal, Consultant in dental public health Leeds PCT, LS16 6QG
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The ethics of water fluoridation have been widely debated by experts in ethics(1 2 3), by the Courts (4 5 6), by citizens’ panels (7), and in the media. Varying, and sometimes conflicting, views have been expressed. Different people will undoubtedly take different views on ethical issues. The fact remains that fluoride confers substantial benefit to communities that receive it. Whether water fluoridation is medication is irrelevant as the Medicines Act clearly does not apply to fluoridation which is covered in separate legislation, namely the Water Act 2003. The issue was debated in Parliament, in both Houses, and subject to a free vote. Parliament determined that decisions about the implementation of fluoridation should be made by Strategic Health Authorities after careful and widespread public consultation which could, of course, include further debate about the ethics of fluoridation. 1. Fottrell F (Chairman). Forum on Fluoridation Ireland. Dublin: Stationery Office, 2002 http://www.dohc.ie/publications/fluoridation_forum.html. 2. Harris J. The ethics of fluoridation. Liverpool: British Fluoridation Society, 1989 http://www.bfsweb.org/facts/ethics/ethicsharris.htm. 3 Holt R, Beal J and Breach J Ethical considerations in water fluoridation in Bradley P and Burls A Ethics in public and community health, Routledge, London, 2000 4. Kenny MJ. FLUORIDATION. Judgement delivered by Mr Justice Kenny in the High Court, Dublin, 1963. Dublin: Department of Health, 1963. 5. Chief Justice O'Dalaigh. FLUORIDATION. Judgement of the Supreme Court of Ireland delivered by Chief Justice O'Dalaigh 3rd July, 1964. Dublin: Department of Health, 1964. 6. Jauncey L. Opinion of Lord Jauncey {Iin causa} Mrs Catherine McColl (A.P.) against Strathclyde Regional Council. Edinburgh: The Court of Session, 1983. 7. NICE Citizens Council. Mandatory Public Health Measures. London: NICE, 2005 http://www.nice.org.uk/page.aspx?o=274599. Competing interests: None declared |
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Dr Barry Cockcroft, Chief Dental Officer for England Department of Health, New Kings Beam House, 22 Upper Ground, London, Se1 9BW
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Dear Dr Godlee ‘Adding Fluoride to Water Supplies’ (Cheng KK. et al. BMJ, 6 October) We welcome the opportunity presented by the paper Adding Fluoride to Water Supplies (Cheng, Chalmers and Sheldon, 2007) to restate our view that fluoridation has already made a major contribution to reducing the burden of dental disease and offers the potential for addressing persistent inequalities in oral health. We recognise that, as with other health measures, safety should continue to be monitored and the ethical dimension discussed. Naturally, we wish first to address the doubts expressed in the paper about the Department of Health’s objectivity. It was of course the Department of Health, which, in 1999, commissioned the University of York to undertake a systematic review of fluoridation. We responded to the report with a commitment to sponsor further research strengthening the evidence base on fluoridation. In 2001, we asked the Medical Research Council to identify and prioritise the research required to inform public policy on fluoridation. Then, in 2003, in accordance with the MRC recommendations, we commissioned the University of Newcastle to investigate the bioavailability of fluoride from artificial and natural sources. The Newcastle study contributed to better understanding of the health effects of water fluoridation. In some parts of the country, drinking water is naturally fluoridated at the level used in artificial fluoridation schemes and generations have been drinking this water without any evidence of systemic ill effects. The report of the Newcastle study (1) concluded that there were no statistically significant differences in bioavailability between artificially and naturally fluoridated water. As a result, we may continue to have confidence in the safety of fluoridation. In planning further research, we have agreed to take account of suggestions that the study be repeated with a larger sample size - within the inevitable constraints of the funding available. We do however make no apologies for promoting the benefits of fluoridation on oral health. We have seen significant improvements in oral health in the last 30 years, but many people still suffer unnecessarily from pain and discomfort from dental disease and there are still inequalities across the country. The most serious consequence is the extraction of teeth under general anaesthetic which carries a small risk of serious injury or, very occasionally, death. There is a strong association between oral health and social class. The probability of having decay experience in primary teeth is about 50% higher in the lowest social group compared with the highest(2). Fluoridation mitigates this association. In Sandwell, the water supply was fluoridated in 1986. Subsequently, the amount of tooth decay in children has more than halved. During the same period, Bolton, with a comparable population mix, saw little change in its children's oral health(3). This contrast is due to the beneficial effects of fluoridation as evidenced by the Systematic Review undertaken by the University of York which found that water fluoridation increases the number of children without tooth decay by 15 per cent and that on average, children in fluoridated areas have 2.25 fewer teeth affected by decay (4). This has been calculated as being equivalent to a 40% reduction in dmft/DMFT(5). There is also increasing evidence of a longer-term beneficial effect of water fluoridation on the dental health of adults with a recent meta-analysis showing a preventive reduction of 27% in dental caries in adults living in fluoridated areas(6). All water supplies contain some fluoride, and it was from observing different patterns of dental decay in areas of differing levels of naturally fluoridated water, that the benefits of fluoride were first observed. We acknowledge that good results can be obtained from regular brushing with fluoride toothpaste. However, tooth brushing alone will not reduce inequalities in oral health because, as the paper acknowledges, use of toothpaste is dependent upon individual behaviour. Targeted fluoridation schemes based on local decision-making - we are not advocating the fluoridation of the whole country - offer greater potential because they are a population-based public health intervention. The York report undoubtedly comprises the most comprehensive review of research on fluoridation to date. We were encouraged by the positive findings on the benefits to oral health and the absence of any demonstrable association with systemic illness but we have taken the criticisms of the quality of research very seriously. We agree that the evidence base on the effects of fluoridation on health needs strengthening. That is why, following the publication of the York review, the Department asked the Medical Research Council to assess priorities for future research in the light of the York work. The MRC reported in 2002 (7) and we are committed to a programme of further research based on that MRC advice. Nevertheless, the fact remains that the York team considered 735 research studies which met the Review’s relevance criteria and could find no evidence of an association between fluoridation and systemic illness. Apart from the protective benefits, the only demonstrable side effect of fluoridating water is dental fluorosis. This is a cosmetic defect of tooth enamel which may range from mild flecking, often undetectable except by a dental expert, to more noticeable marking which may give a small minority of people concern about the appearance of their teeth. With reference to the ecological study from Taiwan (8) cited in the paper, we would like to quote the conclusions reached by the study’s authors: “Our study found an excess rate of bladder cancer that was restricted to females. It seems biologically implausible for fluoride to affect cancer rates for one sex only.” This view is consistent with the Medical Research Council’s report 6 which recommended that research priorities should be determined by plausibility of effect. The question of whether the fluorides added to water should be licensed depends upon whether they should be categorised as medicines. The Medicines and Healthcare Products Regulatory Agency consider that drinking water (whether fluoridated or not) clearly falls within the definition of 'food' for regulatory purposes and is not subject to the licensing requirements for medicines. As the authors indicate, in purely legal terms, the ethical justification for fluoridation depends upon the extent of the benefits to public health. We are satisfied that the persistence of inequalities in oral health provides this justification. Parliament has accepted this argument. Moreover, the circumstances in which fluoridation schemes are introduced was debated in Parliament as recently as 2005 (9) when new requirements for consultations were approved by a large majority in both Houses. Strategic Health Authorities may only make arrangements with a water undertaker to fluoridate an area where they have conducted open, wide-ranging consultations. It is right for those who carry the local responsibility for preventing disease and promoting health to consider the option of water fluoridation as an effective means of reducing the burden of dental decay especially in communities where decay levels remain unacceptably high. The benefits, safety and ethics have rightly been key issues in previous consultations on water fluoridation and will no doubt continue to be at the heart of future consultations. Yours sincerely Dr Barry Cockcroft
Professor Sir Liam Donaldson
References: (1)Maguire A, Moynihan PJ, Zohouri V (2004). Bioavailability of fluoride in drinking water – a human experimental study. Report for the Department of Health, University of Newcastle (2)Steele & Lader (2004): Social factors and oral health in children, Children’s Dental Health in the UK 2003, Office for National Statistics, London . (3) Pitts,N.B.,et al(2005):The dental caries experience of year old children in England and Wales (2003/04) Community Dental Health 22:46-56 (4) McDonagh et al .A Systematic Review of Water Fluoridation, NHS Centre for Reviews and Dissemination, University of York 2000. (5) Worthington,H.V. and Clarkson J. (2003) The evidence base for topical fluorides (editorial) Community Dental Health 20:74-76 (6) Griffin et al (2007): Effectiveness of Fluoride in Preventing Caries in Adults, J dent Res 86(5): 410-415 (7) Water fluoridation and Health: Report of a Medical Research Council Working Group. Medical Research Council. 2002. London (8) Yang CY, Cheng MF, Tsia SS, Hung CF (2000). Fluoride in drinking water and cancer mortality in Taiwan. Environ Res; 82(3):189-193 (9) House of Commons Official Report. Third Standing Committee on Delegated Legislation, 25 Mrach 2005 Col 1-11. Competing interests: None declared |
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Barry A Groves, Independent Researcher, maintains www.second-opinions.co.uk OX7 6LP
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Recently the BMJ debated ‘informed consent’. Not long ago, we were also instructed on ‘the precautionary principle’ and advised to err on the side of caution. Both of these principles are highly relevant in the present climate of pharmaceutical companies’ and other commercial influences over medical practice, and medical practitioners. Cheng et al’s paper on the enduring controversy surrounding water fluoridation is a case in which both of the principles above should be considered. There are thousands of studies into the benefits and adverse side effects of fluoridation. As Cheng et al say, these studies are not of the best quality. But this, in itself, should make us reconsider a practice aimed at whole populations. Many adverse effects of fluoridation have been cited. Let us just explore one: cancer. In the 1970s, a comparison between the ten largest fluoridated cities and the ten largest non-fluoridated cities of the USA showed that, while cancer rates had been similar initially, after twenty years the fluoridated cities had 10% more cancer deaths than the non-fluoridated ones.[1] These figures were checked and confirmed in 1976 by the US National Cancer Institute. The incidence of registered cancers in communities in USA (WHO, 1987) and the Fluoridation Census 1985 by the US Department of Health and Human Services enabled scientists to conduct an epidemiological analysis of the correlation between the two in the United States. They found significant correlations in both sexes between water fluoridation and numbers of cancers of the digestive system (tongue, mouth, pharynx, oesophagus, stomach, colon, rectum and pancreas), the respiratory system (larynx, bronchi and lungs), and the renal system In the sexual organs, contradictions were seen. In women, cancers of the breast, cervix and ovary were increased in fluoridated areas whereas in males those of the prostate, testis and penis were apparently inhibited. The authors considered that the different fluoride effects suggest a possible mode of action of fluoride as an environmental hormone. The dose-response relationship between the numbers of bone cancers in male teenagers and the amount of fluoridation was statistically significant. These significant relationships indicated that fluoride may not be an initiator but a promoter of cancer.[2] Because of concerns that fluoride might cause cancer, in 1977 the US Congress ordered the US Public Health Service to conduct the National Toxicology Program animal study. The results were published in 1990.[3] The study showed that sodium fluoride caused osteosclerosis, oral tumours, osteosarcoma and hepatocholangiocarcinoma at cumulative doses comparable to those ingested by humans over a number of years. In the light of the NTP study on rodents and epidemiologic evidence of an increase in osteosarcoma in boys and young men, especially in fluoridated areas, Dr. Perry Cohn of the New Jersey Department of Health surveyed its incidence in seven counties of New Jersey relative to water fluoridation. He found that in the fluoridated areas, the incidence of osteosarcoma in boys was up to 4.6 times higher than in the unfluoridated areas.[4] In a similar study of three New Jersey municipalities, the figures were up to nearly seven times as high in the fluoridated areas. Cohn also found that the general population in those areas was also five times as likely to suffer a cancer. Cohn’s findings were confirmed in 2001 when Harvard student Elise Bassin was awarded her PhD. Her thesis was based on some brilliant work which showed that young boys being exposed to fluoride in their 6th, 7th and 8th years had a 7-fold increase in osteosarcoma. This important discovery should have been made available immediately. However, it wasn’t until 4 years later that it came to light.[5] It was suspected that this delay might be because of an attempted cover-up of her findings by her professor, Chester Douglass. Chester Douglass has connections with Colgate.[6] In 1996 a Japanese study linked fluoride with uterine cancer.[7] This was hotly disputed, but there is no denying that when fluoridation ceased, the numbers of cases of uterine cancer went down. Surely there is sufficient here to invoke the precautionary principle, to mandate a halt to current fluoridation and to postpone any proposed future fluoridation schemes at least until such time as it can be shown without any doubt that fluoridation is safe. And as the BFS and others continue to deny any adverse effects from fluoridation, how are health advisers and medical practitioners to adopt a precautionary, and how can members of the public, who are to be consulted before any new fluoridation schemes are agreed, to be able to give informed consent. References 1. Yiamouyiannis JA, Burk D. Fluoridation of public water systems and the cancer death rate in humans. Presented at the 67th Annual Meeting of the American Society of Biologists and Chemists and the American Society of Experimental Biologists. June 1976. 2. K. Takahashi K, Akiniwa K, Narita K. Cancer-promoting power of fluoridation. Paper by presented at the 1998 Bellingham Conference of the International Society for Fluoride Research. 3. Toxicology and Carcinogenesis Studies of Sodium Fluoride (CAS No. 7681-49-4) in F344/N Rats and B6C3F1 Mice. National Toxicology Program Technical Report TR 393: NIH, U.S. Department of Health and Human Services, 1990. 4. Cohn PD. A brief report on the association of drinking water fluoridation and the incidence of osteosarcoma among young males. N J Dept of Hlth, Trenton, New Jersey. Nov 8, 1992. 5. Bassin EB, Wypij D, Davis RB, Mittleman MA. Age-specific fluoride exposure in drinking water and osteosarcoma (United States). Cancer Causes Control 2006; 17: 421-8. 6. "Professor at Harvard Is Being Investigated: Fluoride-Cancer Link May Have Been Hidden". Washington Post, Wednesday, July 13, 2005; Page A03 http://www.washingtonpost.com/wp-dyn/content/article/2005/07/12/AR2005071201277.html 7. Tohyama E. Relationship between fluoride concentration in drinking water and mortality rate from uterine cancer in Okinawa prefecture, Japan. J Epidemiol 1996; 6: 184-191. Competing interests: Author of "Fluoride: Drinking oourselves to death?" |
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Phillip J Colquitt, Technicain/RN Independent Comment
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As a well filled customer of various GP dentists here in Australia, I can say that it is the dentist himself who is currently the main threat to my teeth. Not, as this discussion might suppose, the non-fluoridated state of the water here in Brisbane. Given that having water at all is a far greater concern in this sunburnt country. Taking myself to three different GP dentists, I got three different opinions. It’s truly amazing the offhand way that one said “that tooth probably needs to come out”, while the other two said no such thing about a perfectly well tooth. A specialist prosthodontist was utterly dismissive of the GP dentist’s extraction plan, leaving me with an impression of GP dentists as “wanting work”. Many young folk I’ve met here in Brisbane have perfect teeth, so I feel the pro-fluoride lobby are focused on the negative outcome – those with cavities. The discussion would be far more interesting if it revealed the non-cavitated individual’s fluoridation supplementation technique, if any occurred at all. Further, it cannot be assumed that fluoride in water ends up in people, since water is often filtered, as is my own supply. I don’t know anyone who drinks tap water. Dentists have been separate from medicine’s mainstream, in “dental” schools, when they might reasonably be called “minor orthopaedic surgeons”(of the mouth). Tooth is bone. Possibly due to this “dental” isolation, many readers may not know of the old dental practice of “extension for prevention[1]” – this basically means that you get a filling where you don’t need one, because the dentist is allowed to do that. The theory is/was that the filling material is more impervious to cavitation than natural tooth. And now you’re getting fluoride you don’t need, because the government is allowed to do that(proposed). By all means, fluoridate. I’ll just refuse to drink it. 1: Rossomando EF. Minimally invasive dentistry and the dental enterprise. Compend Contin Educ Dent. 2007 Mar;28(3):166, 168. PMID: 17385399 [PubMed - indexed for MEDLINE] Competing interests: None declared |
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Raymond J Lowry, Senior Lecturer in Dental Public Health University of Newcastle NE2 4BW
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Cheng and his colleagues argue that fluoridation might possibly pose a cancer risk and cite a study from Taiwan by Yang et al(1) to support their contention. The Taiwan study compared ten municipalities with a mean natural fluoride level in the water supply of 0.24mg/litre with ten matched municipalities with a fluoride level of <0.01mg/litre. (There are no artificially fluoridated supplies in Taiwan.) Yang et al made twenty-six site-specific comparisons, and in one of these comparisons showed in females a statistically significant (P <0.05 ) increase in bladder cancer. Yang et al suggested that it was biologically implausible for water fluoridation to cause bladder cancer in females and not in males, and that with multiple comparisons one significant difference might have been due to chance. The authors concluded that overall their study, supporting the views of many others “does not provide evidence that fluoridation of the water supplies is associated with an increase in cancer mortality in Taiwan”. Ray Lowry BDS MBChB FFPH References 1. Yang CY, Cheng MF, Tsai SS, Hung CF. Fluoride in drinking water and cancer mortality in Taiwan. Environ. Res. 2000;82(3):189-193. Competing interests: None declared |
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C Albert Yeung, Consultant in Dental Public Health Lanarkshire NHS Board, Hamilton ML3 0TA
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Cheng et al questioned the ethical issue of water fluoridation surrounding informed consent and human rights. [1] However, there is another side of the coin. Clearly there is scope for different points of view on the ethics of any major issue of public policy, including water fluoridation. Anyone who takes up the position that the individual has the right to decide the precise composition of water supply is unlikely to accept water fluoridation as anything less than an intrusion. Does that mean he or she can prevent the chlorination of water simply because of a personal aversion to chlorine? [2] Drinking fluoride-free water is not a basic human right but a question of individual preference. In a society where people come together for mutual benefit, it is a question of balancing such personal preferences against the common good arising from the lower levels of tooth decay which water fluoridation brings. Individuals cannot make decisions about the composition of the public water supply. These decisions must be made at the community level. The minority who have an ideological objection to water fluoridation do not have a right to impose excess risk on the majority, just because of their personal preference. It could be argued that where there is majority community support, it is unethical not to fluoridate water supply. 1 Cheng KK, Chalmers I, Sheldon TA. Adding fluoride to water supplies. BMJ 2007; 335: 699-702. (6 October.) 2 British Fluoridation Society. One in a Million – the facts about water fluoridation. Manchester: British Fluoridation Society, 2004. Competing interests: None declared |
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Christopher Exley, Reader Keele University ST5 5BG
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I was surprised that no mention was made of the role that fluoride plays in increasing human exposure to aluminium via gastrointestinal absorption? Aluminium binds fluoride with great avidity and fluoride in drinking water will both facilitate the gastrointestinal absorption of aluminium which is coincidentally present in drinking water but more importantly it will increase the absorption of aluminium from ingested foodstuffs and other beverages. Fluoridation of the potable water supply will lead to higher human body burdens of aluminium. Whether a higher body burden of aluminium should be avoided is, of course, another debate. Competing interests: None declared |
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Ian Jones, Retired GP None
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Cheng et al (1) fail to make any mention of the adverse impact that dental caries has on the quality of life of many thousands of people – despite the shocking story in the News section of the same issue (2) concerning a youth who died following a dental infection. Of course that child’s death was, thankfully, a rare event. Nevertheless tooth decay causes pain and misery in a significant number of adults and children in this country on a daily basis; before I recently retired from general practice in Bolton – where the water supplies are not fluoridated – I saw at least one patient each working day with problems arising from dental caries. I was encouraged to read Prof Griffiths’ pragmatic approach (3) – he is convinced of the benefits of water fluoridation, and since he could detect no evidence of harm, he, as Regional Medical Officer of the largely fluoridated West Midlands, sensibly resisted any attempts to deprive his population of those benefits. I look forward to the time when I and the rest of the population of Greater Manchester can share Birmingham’s good dental health. Ian Jones, MBBS MSc References: 1. Cheng KK, Chalmers I, Sheldon TA. Adding fluoride to water supplies. BMJ 335 pp699-702 2. Tanne JH. Future of US children’s health insurance still uncertain. BMJ 335 p 685 3. Griffiths R. Fluoride: a whiter than white reputation? BMJ 335 p 723 Competing interests: None declared |
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Stephen T. Holgate, MRC Clinical Professor of Immunopharmacology IIR Division, Level F, Southampton General Hospital, Southampton, SO16 6YD., Trevor A Sheldon
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Dear Editor We are surprised that both the Chief Dental and Chief Medical Officers for England consider that the Newcastle study on bioavailability (1) “contributed to a better understanding of the health effects of water fluoridation”. The researchers themselves urged that “caution is necessary when interpreting the results” .(1) It is disappointing, therefore, to see such senior public health officials make the simple error of assuming that “no statistically significant differences in bioavailability between artificially and naturally fluoridated water” has any meaning when the study was far too small to find scientifically important differences. Interestingly, despite the small size however, the Newcastle study did report a statistically significant difference in the relative bioavailability of fluoride in drinking water (plasma Fp%) at both 3 hours (27%) and 8 hours (36%) follow up (mean difference in Fp% (0-8) = 35, 95% CI: 5.9, 64.5)(1). However, the authors removed one of the 20 data points, which they determined was an outlier because “one subject appeared to have much larger values ... than other subjects” . This manoeuvre reduced the statistical significance below the critical value. The trend of increased bioavailability in artificially fluoridated water, however, remained in all plasma comparisons (Tables 5, 6 and 7).(1) The discarding of an outlier (removing 5% of the data) to eliminate an ‘inconvenient’ statistically significant result, is not good practice and raises doubts about the validity of the inferences. Given the weaknesses in the study design and analysis it is surprising that the CDO an CMO should state that “as a result, we may continue to have confidence in the safety of fluoridation.” 1. Maguire A, Moynihan PJ, Zohouri V (2004). Bioavailability of fluoride in drinking-water – a human experimental study. Report for the UK Department of Health. www.ncl.ac.uk/dental/research/diet/fluoride_bioavailability_report.htm Competing interests: None declared |
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Douglas W Cross, Independent Consultant in Environmental Analysis Ulverston, Cumbria LA12 8EE
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In attempting to establish an ethical basis for water fluoridation Professor Yeung repeats the common error of fluoride proponents in claiming that a supply of unfluoridated water is not a human right, and that it is a matter of balancing personal preferences against the common good. Human rights come in two flavours – relative and absolute. In postulating an over-riding 'common good' for the practice of water fluoridation, Yeung implies that the practice has some clear beneficial effect on the target population and that it also has no equal or greater adverse counter-effects, either on that population or on the rest of society. As the authors of the York Review made clear, and as the present authors also assert, the evidence base on which such assumptions are based is unsound.
In fact, the prohibition on medication without consent is an absolute right. It originates from a universal determination to prevent the recurrence of the atrocities that the Neuremburg Convention prohibited, and is well defined in specific terms in both the Council of' Europe's Convention on Biomedicine and Human Rights and in the EC's Charter of Fundamental Freedoms, both of which the British Government is curiously reluctant to endorse. The British Home Office Guidelines on the Human Rights Act make it quite clear that the right to refuse medication is absolute except in only two instances: where failure to treat an individual without consent would expose the general public to a real and substantial public health threat, or where a person is mentally incapable of making an informed condition. Bad teeth are not a threat to public health, nor is there an over-riding need to balance one person's bad teeth against another's risk of fluorosis or osteosarcoma. The cause of children's bad teeth can be directly linked to their diet and dental hygiene, both of which are the responsibility of their parents, not the general public at large nor even the State. Alternative dental treatments are available to each individual that do not expose the general public to risks of adverse medical effects, nor even take away their choice of whether or not to accept such medication. Since the incidence of dental caries has declined substantially throughout both the UK and unfluoridated Europe, there is no justification for attempting to impose medication by fluoridation, for which the evidence of its supposed efficacy is, at best, dubious. When new fluoridation schemes are proposed, invariably the target population is described by fluoridation advocates as having the worst teeth in the region, an argument relying on a selective relative comparison rather than an absolute comparison with the overall trend. Justifying public medication without consent on the basis of such flawed arguments merely reinforce public aversion to fluoridation. In fact, since the practice is contrary to law, the issue of whether or not the public right not to receive fluoridated drinking water is a relative or absolute rights does not arise. As I have already stated, the State has no authority to perform a criminal act of assault upon the public, regardless of its purported good intent. Competing interests: None declared |
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Douglas W Cross, Independent Consultant in Environmental Analysis Ulverston, Cumbria LA12 8EE
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The debate on whether or not water fluoridation is ethically permissible follows the inevitable course of woolly arguments supported by a predictable collection of quasi-legal assertions. Dr. John Beal's claim that the Medicines Act does not apply to fluoridation because it is covered by the Water Act 2003 is naïve.[1] The assumption that the fluoridation clauses in the Water Act 2003 allow the British Government to circumvent the provisions of the legal constraints on medicines and food in both the European and English legislation is entirely wrong. Fluoridated water is, and will remain, legally a medicinal product, irrespective of the Medicines and Healthcare Products Regulatory Authority's (MHRA) refusal to grant it a medicinal licence.
The issue of immediate concern, raised again by Cheng et. al. last week, is why the MHRA has persistently avoided classifying this product as medicinal, despite the clear definitions provided by both the Medicines Directive and the European Court of Justice (ECJ) decisions. Dr. Beal's references to Court decisions that appear to support his case are selective. They rely on 1960's decisions in Irish Courts which have long been overtaken by much more recent ECJ decisions that apply throughout the whole of the European Community. His minimal reference to the Jauncey judgement of 1983 implies that this supports his own ethical stance, yet in fact it does no such thing. It merely draws public attention to a fundamental defect in the proponents' case; Lord Jauncey made it absolutely clear that fluoridated water is a medicinal product, an aspect of his decision that proponents always gloss over. Nor are his reference sources on medical ethics of more weight. Citing the Chairman of the Irish Fluoridation Forum as an 'expert' on ethics gives the impression that the Forum provides a reliable reference on the credibility of this source. In fact the Forum's study attracted opprobrium from the scientific community. Burgstahler et al commented: In our view, the report fails to provide a proper scientific review of the many health concerns raised about the practice of water fluoridation in Ireland, and elsewhere. Out of a total of 295 pages, only 17 pages (pp. 108-124) are devoted to health issues other than dental fluorosis. Of these, a heavy reliance is placed on reviewing "other reviews" some of which are dated. Incredibly, for a study which took two years, only 2 pages (pp. 122-3) are devoted to an independent analysis of specific health studies. [2] Dr. Beal also cites Prof. John Harris as an authority on the ethical basis of fluoridation His widely quoted but ethically bizarre view is that 'It does not in any way conflict with basic human rights (there is no such thing as the right to drink fluoride-free water - only a personal preference to do so) is supported by a quotation attributed to Lord Avebury; ‘No consumer has the right to dictate the chemical composition of water, a recipe for anarchy.[3] In fact, the Offences Against the Person Act 1861 prohibits the administration of any 'noxious or poisonous' substance, including any material containing such substances, to any person. Sodium fluorosilicate is specifically listed as a poison in Part II of the UK Poisons List Order 1982. Fluorosilicic acid, the fluoridation substance of choice and somewhat more toxic than the sodium salt, contains another Part II listed poison, hydrogen fluoride. Adding either to the public drinking water supply could be interpreted as a violation of the 1861 Act. Although approximately one in eight people in any population exposed to fluoridated water may develop disfiguring dental fluorosis 'of cosmetic concern', the assumption that there is enough dilution of these poisons for the provisions of the Act not to apply is unsound. Prof. Harris's contention that there is no right to drink fluoride-free water is therefore wrong – it has been prohibited by the general provisions of the Act for 146 years. Water fluoridation has little scientific credibility, and is undoubtedly both a violation of medical ethics and of human rights. The legal frameworks under which it is imposed in the UK and the USA differ [4], but the underlying ethical objections remain based on sound principles of respect for human dignity and choice. Lord Avebury's proposal that no consumer has the right to dictate the chemical composition of water is, of course, precisely the point made by the opponents of fluoridation. Governments, Departments of Health and Health Authorities are all composed of consumers who apparently wish to do precisely this, by ordering water companies to add fluorosilicates to the drinking water. A recipe for anarchy indeed! References 1.Cross D. Medication by intent – the case against fluoridation. BMJ Rapid Responses 5th October 2007. http://www.bmj.com/cgi/eletters/335/7622/699#178017 2.Burgstahler A, Carton R J, Connett P, Hirzy W J, Howard C V, Kennedy D, Limeback H, Masters R, Murakami T, Spittle B and Susheela A K. A scientific critique of the Fluoridation Forum Report, Ireland 2002. Voice of Irish Concern for the Environment, Dublin. http://www.voice.buz.org/fluoridation/Fluoride%20Critique.pdf 3.The ethics of water fluoridation. In 'One in a Million', Ed. Catherine Stillman-Lowe, British Fluoridation Society, Manchester UK http://www.bfsweb.org/One%20in%20a%20million/10%20ethics.pdf 4.Cross D and Carton R J Fluoridation: A Violation of Medical Ethics and Human Rights. Int. J. Occup. Environ. Health 9(1):24-29. 2003. Competing interests: None declared |
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Earl Baldwin of Bewdley, Cross-Bench Peer House of Lords, SW1 OPW
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Cheng et al(1) are well placed to sound cautionary notes about fluoridation since two of the authors were involved in the only scientifically defensible assessment of the evidence that has been done. I also served on the advisory panel to the York review,(2) after two years of parliamentary questioning of the rationale for fluoridating. It is depressing then to see restatements of old positions, instead of much-needed engagement with their arguments. After 60 years we are still not clear about fluoridation’s benefits, even less clear about harms, and least clear of all about reductions in dental health inequalities. York and the Medical Research Council(3) are not the only bodies to have outlined areas of needed research. Yet while Government says it accepts this, fluoridation continues, new schemes are encouraged, and in the seven years since York one small and inconclusive study has been funded.(4) This looks more like lip service than a commitment to good science. Can promoters of fluoridation still not see the possible risks to 5 million people who are taking a lifetime’s uncontrolled dose of fluoride? And how do they interpret Cheng’s WHO graph which shows that several European countries do quite well without it? Medical ethics are crucial. Cheng at al have pointed to the GMC’s(5) and Council of Europe’s(6) codification of the need for a patient’s consent before treatment. Do fluoridators believe this well accepted principle is wrong, and if so why? One would like to hear why fluoridation should be unique, when not even vaccination is compulsory. The issue here is medical treatment, since medical claims are being made. (Dr. Yeung misses the distinction that chlorine is intended to treat water, whereas fluoride treats people.) The Chief Officers in their response conflate the scientific and ethical arguments as though strong benefit could override patients’ lack of consent, citing Cheng at al for an argument they did not use, and claiming Parliamentary support for an ethical standpoint that was not put to the vote. Meanwhile the Medicines and Healthcare products Regulatory Agency may be open to challenge in the courts for its failure to adhere to the European Directive on medicinal products;(7) the fact that a substance is governed by some other law, e.g. the Water Act referred to by Dr. Beal, is no defence to this.(8) To avoid a continuing dialogue of the deaf, it would be helpful if defenders of fluoridation could address Cheng et al’s points. And in the interests of good science the Government, which deserves praise for setting up the York review, should show its continuing good faith by providing for the review’s updating and incorporation where it properly belongs, in the Cochrane Library. 1. Cheng KK, Chalmers I, Sheldon TA. Adding fluoride to water supplies. BMJ 2007;335:699-702. 2. NHS Centre for Reviews and Dissemination. A systematic review of water fluoridation. York: NHS CRD, 2000. 3. Medical Research Council. Working group report: water fluoridation and health. London: MRC, 2002. 4. Maguire A, Moynihan PJ, Zohouri V. Bioavailability of fluoride in drinking-water - a human experimental study. Report for the UK Department of Health, June 2004. Newcastle upon Tyne: School of Dental Sciences, University of Newcastle, 2004. 5. General Medical Council. Seeking patients’ consent: the ethical considerations. London: GMC, 1998. 6. Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. Council of Europe, 1997. 7. 2004/27/EC on medicines for human use, Article 1.2. 8. 2004/27/EC on medicines for human use, Article 2.2. Competing interests: Co-Chair (unpaid), All Party Parliamentary Group Against Fluoridation |
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Doris M Jones, MSc, Independent Researcher IG2 6DZ
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This is a welcome article on the vexed topic of fluoridation.
One strong argument against fluoridation lies in the fact that caries in 12 year olds have decreased universally in European countries over the past 30 years, irrespective of fluoridation. The reasons for discontinuing water fluoridation in Germany are known: The German Association of Gas and Water Employees prepared a detailed report in 1975 considering all then available evidence. Their report, supported by 485 references, concluded that fluoridation was foreign to nature, unnecessary, unsatisfactory, illegal according to two basic German laws, irresponsible, harmful to the environment, uncontrollable and inefficient. (1) The graph of the Cheng et al article shows that caries have declined in Germany between 1975 and 2005. This review stresses the methodological difficulties in assessing (with some accuracy) the effects of long-term exposure to fluoridation, as identified in the 2000 York Systematic Review. Nevertheless, some chronic and serious conditions are mentioned (i.e. a possible higher incidence of bladder cancer and hip fractures) apart from dental fluorosis. Considering the authors’ concerns over such difficulties, it is disappointing that Paul Connett’s 2004 comprehensive review ’50 Reasons to oppose fluoridation’ (2) is given as an example which overstates the evidence of harm. Additional problems identified in Connett’s review and supported by many references include effects of fluoridation on numerous enzymes, on thyroid functioning with resultant further increased risks of depression, fatigue, weight gain, muscle and joint pains, higher cholesterol levels and heart disease i.e. the most common health problems now experienced by large sections of the UK population. Furthermore this review mentions the risks of skeletal fluorosis and arthritis, the fact that certain sections of the population are particularly vulnerable to toxic effects of fluoride i.e. the elderly, diabetics, people with poor kidney functioning and those suffering from malnutrition. There is also a strong likelihood that fluoridation may be linked to Alzheimer’s Disease. All of these are significant health problems, and if even a small reduction in their frequencies could be achieved by eradicating fluoridation, the UK government and the NHS would save millions of pounds in expenditures, not to mention huge additional costs associated with implementing further fluoridation schemes in the country. References 1) Dokumentation zur Frage der Trinkwasser-Fluoridierung, DVGW Schriftenreihe, Wasser, Nr.8, 1975 2) www.fluoridealert.org/50-reasons.pdf Competing interests: None declared |
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Gillian E Swan, Senior Scientific Officer, Food Standards Agency Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH
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The Food Standards Agency notes Dr Mansfield’s comments (rapid response 5 October) regarding the estimate of fluoride intake in the National Diet and Nutrition Survey of adults 19-64 years(1). We agree with Dr Mansfield that in adults only ca. 50% of ingested fluoride is excreted in urine and accept that the NDNS report should not have implied that fluoride excretion equals fluoride intake. The most sensitive effect of fluoride in humans is considered to be dental fluorosis, a developmental defect of the tooth enamel occurring in children aged under 8 years. The COMA Dietary Reference Values report(2) states that intakes of 0.05mg/kg body weight for adults and children aged over 6 years are safe. This is based on a calculated typical intake from food and fluoridated water for a 60kg adult, that has not been shown to be associated with adverse effects. However more recent reports have proposed higher upper limits for fluoride intake. In 2006 the European Food Safety Authority recommended an upper limit of 0.12mg/kg/day for adults and children aged 9 years and over (equivalent to a upper limit of 7mg/day for a 60kg adult)(3). The US Dietary Reference Intakes report recommends an upper limit of 10mg/day for adults and children over 8 years(4). Applying these upper limits would indicate that the proportion of adults in the NDNS with fluoride intakes above the safe level is substantially lower than Dr Mansfield’s estimate. The Committee on Toxicity reviewed the evidence then available on fluoride intake in 2003 and concluded that no adverse effects other than mild to moderate dental fluorosis would be expected to be associated with fluoride intake from food, either in adults or in children at the intake levels in the UK(5). We are arranging for an erratum note to the NDNS report to go on the FSA website. 1. Henderson L, Irving K, Gregory J, Bates CJ, Prentice A, Perks J, Swan G & Farron M. National Diet and Nutrition Survey: adults aged 19 to 64 years. Volume 3: Vitamin and mineral intake and urinary analytes. London: TSO, 2003). 2. Department of Health. Dietary reference values for food energy and nutrients for the United Kingdom. London: HMSO, 1991 (sixth impression 1994) 3. European Food Safety Authority. Scientific Committee on Food. Tolerable upper intake levels for vitamins and minerals. 2006. Available on-line at http://www.efsa.europa.eu/EFSA/Scientific_Document/upper_level_opinions_full -part33.pdf 4. US Institute of Medicine. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D and fluoride. National Academies Press 1997 5. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (2003). Statement on fluorine in the 1997 Total Diet Study. COT Statement 2003/03. Available on line at: http://www.food.gov.uk/multimedia/pdfs/fluoride.pdf Competing interests: None declared |
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Bill Osmunson DDS, MPH, Cosmetic Comprehensive Dentist Bellevue, Washington 9804
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The BMJ needs to be commended for further opening the scientific debate on fluoridation. For the first 25 years of dental practice I promoted the addition of fluoride to water, in part because I thought I could “see” the difference between those on fluoridated water and those without. Unfortunately, I was actually comparing socioeconomics rather than fluoridation. As more patients have come in requesting extensive cosmetic dentistry, sometimes costing tens of thousands of dollars to correct their dental fluorosis, I decided it was time to look at the sources, dosage, efficacy, and benefits of ingested fluoride. Looking at the current literature was like a knee in the gut.1 FLUORIDE EXPSURE: Clearly fluoride exposure has increased over the last 60 years. Dental fluorosis is up 50% to a third of children. More dental and medical products and medications contain fluoride. Permitted residue levels from fluoride based pesticides and post-harvest fumigants (ProFume, Dow Agro Chemical) have significantly increased in just the last decade. Mechanically deboned meat can be much higher in bone/fluoride content. Grape products and some tea have high levels of fluoride. Apparently no agency is the legal intermediary, the doctor, responsible for monitoring the public’s total exposure to fluoride. Some people are more sensitive to chemicals and unable to excrete excess fluoride. Synergistic effects from groups of chemicals are relatively unknown. It appears any benefit of fluoride is from a topical application and not from ingested fluoride. BENEFITS OF FLUORIDATION: “Evidence for whether an intervention works when applied in the community at large is referred to as its effectiveness. . . . Effectiveness studies more accurately reflect results that may be expected from the implementation of interventions.”2 If fluoride actually provides a “life time” reduction of dental decay, certainly after 60 years of fluoridation we should see clear evidence of effectiveness. Unfortunately, comparing developed countries finds all have reduced dental decay to similar levels regardless of fluoridation. Comparing states within the USA based on the percentage of the population fluoridated finds no improved dental health or reduction of decay regardless of the percentage fluoridated. Comparing similar states such as Washington State (59% fluoridated) with Oregon State (19% fluoridated) actually finds slightly better dental health in the less fluoridated Oregon. Comparing counties within states finds similar oral health, with similar socioeconomics, regardless of fluoridation.3 Studies on fluoridation have not included the confounding factor of delayed tooth eruption or looked at life time benefits.4 It is a flawed assumption to expect fluoridated children with fewer cavities will "therefore" have a life time of fewer cavities. Several studies have actually found an increase in dental decay and tooth loss with fluoridation. Without clear, undisputed, life time benefits from fluoridation , any risk or expense is unacceptable. Communities have stopped fluoridation with no increase in dental decay.5 The experiment of fluoridation is currently being promoted without good scientific and ethical review of continued life time benefits. The US National Academy of Sciences 2006 report confirmed potential benefits from fluoridation are during the development of the tooth, up to about age 8. It makes no sense to have a lifetime uncontrolled dose of fluoride for everyone when the potential benefits are only up to age 8. Lifetime exposure must be considered. DENTAL RISKS OF FLUORIDATION: As a Cosmetic Dentist, it is not uncommon to have patients receive gorgeous porcelain veneers to correct their dental fluorosis, white and brown damage from too much ingested fluoride. Costs range from several hundred dollars to well over $25,000 and need to be retreated every 10 to 20 years for life time costs which may exceed $100,000 per person. With a third of children having dental fluorosis, the true costs for cosmetic damage to teeth alone is in the trillions of dollars. A side effect seldom raised by cosmetic dentists. Certainly most will not seek treatment, but the public liability for damage is significant. Public Health Dentists seldom provide cosmetic dentistry and therefore under rate the increased dental damage from fluoridation. MEDICAL RISKS OF FLUORIDATION: Many committees reviewing fluoridation are composed of Dentists. It is not in the perview of Dentistry to diagnose thyroid, hormonal, skeletal, kidney, liver, brain, skeletal disorders or cancers outside the oral cavity. Epidemiologists, Toxicologists and Medical Professionals unwisely rely on their Dental counterparts to diagnose safety for body organs from fluoridation and Dentists would be practicing outside their scope of training and licensure to appropriately weigh the gravity of medical side effects. Historic ground was covered in the USA when scientists opposed to fluoridation were permitted on the National Academy of Science 2006 report to the US Environmental Protection Agency which unanimously found the EPA’s Maximum Contaminant Level was not protective.6 The US Center for Disease Control and American Dental Association have cautioned infants should not be given fluoridated water or fluoridated water be used for making infant formula.7 More than 3 out of 4 infants receive formula. Consider that all are medicated with fluoridation, yet the water is not safe for our most vulnerable, our babies. We are now asking mom’s to haul their infant, it’s food, toys, clothes, and now water. Parents in third world countries can usually boil their water to make it safe for infants, but many communities consciously put chemicals in the public water which can’t even be boiled out or traditional filters used to make it safe for infants. The biggest problem in the US scientific community is the fear Universities, Medical and Dental Associations and Journals have in permitting discussion, debate and scientific review of fluoridation. One state medical association requested $50,000 for a short private presentation of concerns. Others permit review only by their legal counsel. The BMJ should be commended for their willingness to do what few other scientists are willing to do, open scientific discussion. Bill Osmunson DDS, MPH Aesthetic Dentistry of Bellevue bill@smilesofbellevue.com 1. The CDC also references Horowitz and Ismail 1996, Johnston 1994, Ripa 1990, Stookey and Beiswanger 1995, however all these reviewed topical application of fluoride, not the addition of fluoride to water. http://www2.nidcr.nih.gov/sgr/sgrohweb/chap7.htm 2. http://www2.nidcr.nih.gov/sgr/sgrohweb/chap7.htm 3. National Survey of Children's Health. http://mchb.hrsa.gov/oralhealth/portrait/1cct.htm. http://www.cdc.gov/oralhealth/waterfluoridation/fact_sheets/states_stats2002.htm The National Survey of Children's Health 2003. Rockville, Maryland: U.S. Department of Health and Human Services, 2005 U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau http://www.doh.wa.gov/cfh/Oral_Health/Documents/SmileSurvey2005FullReport.pdf http://www.oregon.gov/DHS/ph/oralhealth/docs/databook.pdf#search='Oregon%20Decay%20experience‘ BRFSS 2002 http://www.dhs.state.or.us/dhs/ph/chs/brfs/02/orahea/dentvisi.shtml http://apps.nccd.cdc.gov/brfss/display.asp?state=WA&cat=OH&yr=2004&qkey=6610&grp=0&SUBMIT4=Go Sample size OR 3509 and WA 12,926 2004 data http://www.cdc.gov/oralhealth/waterfluoridation/fact_sheets/states_stats2002.htm National Survey of Children's Health. http://mchb.hrsa.gov/oralhealth/portrait/1cct.htm U.S. Department of Health and Human Services, http://www.fluoridationcenter.org/papers/2002/cdcmmwr022102.htm http://quickfacts.census.gov/qfd/states/41000.html 4. Our analysis shows no convincing effect of fluoride-intake on caries development." Komarek A, et al. (2005). A Bayesian analysis of multivariate doubly-interval-censored dental data. Biostatistics 6:145-55. 5. Kugel (sp) and Fischer 1997, Seppä et al. 1998 6. www.nap.edu/catalog/11571.html; Fluoride in Drinking Water: A Scientific Review of EPA’s Standards 2006 7.http://www.cdc.gov/fluoridation/safety/infant_formula.htm; www.ada.org; see also Pizzo G, et al Community water fluoridation and caries prevention: a critical review, Clin Oral Investig. 2007 Feb 27. Competing interests: None |
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Lyn Mynott, Chair Thyoid UK, Clacton on Sea, CO16 8QF
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The subject of how the thyroid gland is affected by fluoride seems to have been forgotten. Since the late 1800's it has been shown that fluoride causes goitre. "Goldemberg publishes extensively between 1921 and 1935 on his findings of applying fluorides as anti-thyroid medication." May, Litzka and Gorlitzer von Mundy in the 1930’s, treated Graves’ disease, using fluoride compounds orally, in ointments, and fluoridated water baths. Hypothyroidism is on the increase and research should be done to see if fluoride is the culprit before it is decided to fluoridate people against their will. More information is available on the effects of fluoride on the thyroid from http://bruha.com/pfpc/html/thyroid_history.html Competing interests: None declared |
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Elizabeth A McDonagh, Chairman, National Pure Water Association Melton Brand farm, Melton Brand, Doncaster. DN5 7EB
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H Trendley Dean’s early studies pre-empting fluoridation were funded by an aluminium industry seeking a profitable outlet for fluoride by- products and also to smoke-screen fluoride air-pollution1. Their aim was to ascertain at what fluoride concentration dental fluorosis would raise objections. 1 ppm caused mild mottling in about 10% of the population, considered acceptable. The decision was all about teeth. No animal studies were conducted to determine the effect of fluoride on other body structures. In 1945, Grand Rapids became the first town to be fluoridated. Biochemistry was in its infancy. In a book on animal nutrition2, published around 1949, fluorine is classified as a ‘Harmful Mineral Element’ and ‘a cumulative poison’. Farmers understood that it damaged cattle, but knowledge of the true nature of fluoride was soon lost in the hype to use the substance as a prophylactic against tooth decay and to promote the widespread adoption of fluoridation. The late Dr John Yiamouyannis, biochemist, explained some of the effects of fluoride on cellular metabolism.3 The highly electro-negative fluoride ion disrupts the hydrogen bonds so essential to the structure of proteins. Enzymes are inhibited, and metabolic pathways compromised. Could fluoride and other environmental pollutants be behind the increase in allergies and chronic fatigue we are currently experiencing? In their BMJ article, Cheng, Chalmers and Sheldon state:- “It (fluoride) affects plaque by altering the ecology of the dental plaque and reducing acid production”. This may be interpreted as “Fluoride is a very effective anti- bacterial agent against the bacteria which normally produce acid from carbohydrate residues in the mouth.” The concentration of fluoride necessary to achieve this effect is not specified but we can surmise that the level in typical toothpastes (1400 ppm) will be somewhat more effective than the 1ppm used in fluoridation schemes. UK toothpaste packages warn to use only a pea-sized piece and to supervise children to make sure they do not swallow. In the US, all fluoride toothpastes are obliged to carry a distinct poison warning. So can we regard 1ppm as toxicologically insignificant? Hardly. In the 1950s and early 1960s, thalidomide was heavily promoted as safe and effective. Even at high doses thalidomide was declared to be “so atoxic that it may be administered to even newborn and infants” The claim was mainly based on the fact that it had been practically impossible to kill experimental animals by injecting any amount of the drug in a single dose. This lack of acute toxicity was considered advantageous because it avoided suicides and accidental poisonings. “However, it has long been recognised by pharmacologists that a low acute toxicity does not guarantee that a drug will be harmless when taken in repeated low doses over a prolonged period of time.”3 In contrast to Rod Griffith’s anecdotal piece, Paul Connett’s 50 Reasons to Oppose Fluoridation (accessible from www.fluoridealert.org ) is a serious piece of academic work, fully referenced and drawing on research from all over the world. It is difficult to see how Cheng, Chalmers and Sheldon can state categorically that it overstates the harm from fluoridation while they admit that “evidence on the potential benefits and harms of adding fluoride to water is relatively poor”. Fluoridation has become a dangerous orthodoxy and it is essential that people with scientific understanding study all aspects of the issue and come to their own logical conclusions. For too long, doctors and politicians have been propagandised by the British Fluoridation Society and open debate has been stifled. In my considered opinion, fluoride from all sources is best avoided. To add it to the water supply of millions is about as rational a health intervention in the twenty-first century as was the bleeding of King George the Third in the nineteenth. References 1 Bryson, The Fluoride Deception Seven Stories Press, NewYork (2004) 2 Lowe, L.T., The Student’s Handbook to Animal Nutrition Littlebury & Company Ltd, The Worcester Press, Worcester. (undated 1949?) 3 Henning Sjostrom and Robert Nilsson Thalidomide and the Power of the Drug Companies Penguin (1972) Page 43 4 Yiammouyannis, J, Fluoride the Aging Factor Health Action Press 3rd edn (1993) Elizabeth A McDonagh BSc(Hons), Cert. Ed. Chairman National Pure Water Association Competing interests: Chairman (unpaid) National Pure Water Association |
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Ian E Packington, independent tutor 42 Huntington Road, York YO31 8RE
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bmj.com Rapid Responses for Cheng et al., 335 (7622) 699-702 Gestational Deficits without Economically Viable Dental Benefits Condemn Mass Fluoridation Ian E Packington MA Cert Tox Cheng et al show that net caries rates across Europe have declined strongly irrespective of fluoridation status - note that decay rates in Eire (74% F) are parallel to England and Wales (10% F) but remain 10% higher. For mass fluoridation to remain acceptable dental public health policy it must be reconfirmed as economically effective in reducing overall caries experience and essentially harmless in the light of all scientifically validated evidence. It is clear that political priorities, and not scientific integrity, have dictated from the outset how such a manifesto will be maintained. York CRD’s Evidence for Dental Benefits York selected ‘before/after’ studies (baseline data for two populations, one subsequently fluoridated) to compare changes over time a) in caries prevalence and b) in net caries rates. Using meta-analysis they inferred statistically significant caries reductions for both indicators. But their handpicked “controlled trial” datasets were all for child populations up to age16: ages 5 and 8 for deciduous dentition; ages 8,12 and 14/15 for permanent dentition. DMFT scores do not level out until at least 20-25. Data came from a mere 10 or so papers spanning over 50 years from 1945 to 2000. It came from several countries (e.g. Chile, E. Germany, rural Taiwan) whose dental care provision was never strictly comparable with U.K. norms, and where caries was virtually uncontrolled before fluoridation. All datasets that provided variance estimates were pooled to give ultimately “14.6% [-5% to 64%] more children without caries experience, and a net mean reduction of 2.25 [0.5 to 4.4] dmft/DMFT”. These caries indicators invariably move in opposite directions in time. They lack contextual meaning. They cannot apply to the U.K. where, following the introduction of fluoride pastes and rinses, all recent datasets show an apparent net gain of ~1 child tooth at these pre-selected ages. Note, too, how rapidly the percentage of caries-free children is falling. York’s data [Table 4.10, p.23] shows that the excess caries-free fractions attributable to fluoridation fell from age 5:13.2% to 8:7.2% (primary dentition) and from 8:35.6% to 12:13.1% to 14/15:8.8% (secondary). Differences must become negligible by the early 20s, and the same applies to DMFT differences [1]. Fluoridation schemes have high capital costs plus significant running and depreciation costs [2]. It is hard to see how new U.K. fluoridation schemes could be cost-effective, or if they ever were. Powerful demonstrations of net dental ineffectiveness come from large scale studies that York CRD were able to ignore [3,4,5]. These all showed that there was no difference in overall (5-17) childhood caries experience between fluoridated, part-fluoridated and unfluoridated populations. The official USPHS analysis [5] did find a residual net DMFS benefit of 1 to 2 surfaces via fluoridation in 1986-7. This relates to caries control on flat, open surfaces. Under fluoridation other carious surfaces may resist enamel and dentinal penetration for a little longer, but it takes far higher oral fluoride concentrations to repair incipient carious sites - hence the recommended daily use of pastes and mouthwashes with 1000-1500 ppm fluoride (500 ppm for younger children). These can give ~25% reduction in net caries scores [6] but fissure sealants on molars can reduce caries scores far more effectively [7]. Decay statistics are ma | |||